Freshman needs help with ISO 13485 Audit Process

S

szszsz

#1
Hi,

I just found this amazing site and it has so many devoted participants.

I am new to ISO 13485, and currently helping my company, a new manufacturer, to apply for ISO 13485 certificate. We have only 15 employees so we are trying to do it by ourselves. We want to use just enough resource to build a quality system that meets the ISO 13485 standards.

Can anyone briefly introduce how an audit runs, such as what types of data auditors will collect, how they will interview employees, what they like to see at the site and what they do not like?

I wish I could ask more specific & technical questions but I just could not.

Thanks.

Jimmy Wu :thanx:
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Re: Freshman needs help with audit process

Hello and welcome to the cove :bigwave:

Auditors each have their own style and methodology, but in general, in a first certification audit they are likely to start with your quality manual (including quality policy and objectives), then they will follow through with a systematic review of your QMS and its various sub-domains. While doing that, they will both verify that your QMS (SOPs etc.) meets all applicable requirements of the standard, and that your SOPs are implemented as written and in compliance with the standard. This may be done through review of documentation, files, records etc. and by staff interview, as well as by direct observation of your premises and practices.

A general answer to some general questions... :)

Cheers,
Ronen.
 
#4
Hi,

I just found this amazing site and it has so many devoted participants.

I am new to ISO 13485, and currently helping my company, a new manufacturer, to apply for ISO 13485 certificate. We have only 15 employees so we are trying to do it by ourselves. We want to use just enough resource to build a quality system that meets the ISO 13485 standards.

Can anyone briefly introduce how an audit runs, such as what types of data auditors will collect, how they will interview employees, what they like to see at the site and what they do not like?

I wish I could ask more specific & technical questions but I just could not.

Thanks.

Jimmy Wu :thanx:
You may be about to make a big mistake! Doing it by yourselves! Has anyone any past experience of implementing a QMS? If not, you will, in all probability, fail! How are you, for example, going to learn how to do internal audits?

Do you have a chosen Certification Body? Why not ask them? It's a good way to get to know them...
 
M

Markaich

#6
Perhaps a good way to start is by undertaking a Lead Assessor course yourself.

When I suddenly found myself in charge of the Quality Function many years ago I realised I had much experience of working within a QMS (from my apprenticeship in a 05-21 compliant system) but absolutely none when it came to managing such a system.

The week's (and about £800) investment was well worth the time and money...it certainly helped me reduce considerably the amount of documentation we had while hosting the most successful BSI certification visit the company had ever had.

My current education and experience is vastly greater than was the case then, but that one week course was perhaps the best foundation I'd had for understanding the requirements of the standard as well as the certification process.

Hope this helps
M
 
S

szszsz

#9
Thanks for the warning. We had person work under 9001 system before. I do not have QMS experience, but I have environmental management system experience. Based on my general experience, an ISO management system should have clear, objective requirements and guidance. Do you mean there are other factors involved in the certification process besides the standards?

For "internal audit" or other required procedures, we bought some templates and standard forms from internet. We will study it and utilize it.

Our main obstacle is that we don't have real QMS audit experience.

We have not chosen a Certification Body. Our production line has not started. I talked to several Registrars and they said they will collect data, visit sites and interview staffs.




You may be about to make a big mistake! Doing it by yourselves! Has anyone any past experience of implementing a QMS? If not, you will, in all probability, fail! How are you, for example, going to learn how to do internal audits?

Do you have a chosen Certification Body? Why not ask them? It's a good way to get to know them...
 
S

szszsz

#10
Thanks!

I will check the course out. Hope there is one in US.

Perhaps a good way to start is by undertaking a Lead Assessor course yourself.

When I suddenly found myself in charge of the Quality Function many years ago I realised I had much experience of working within a QMS (from my apprenticeship in a 05-21 compliant system) but absolutely none when it came to managing such a system.

The week's (and about £800) investment was well worth the time and money...it certainly helped me reduce considerably the amount of documentation we had while hosting the most successful BSI certification visit the company had ever had.

My current education and experience is vastly greater than was the case then, but that one week course was perhaps the best foundation I'd had for understanding the requirements of the standard as well as the certification process.

Hope this helps
M
 
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